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20.12.2012 Official
Journal
of
the
European
Union L
350/55
COMMISSION IMPLEMENTING REGULATION (EU) No 1237/2012
of 19 December 2012
approving the active substance Zucchini Yellow Mosaic Virus — weak strain, in accordance with
Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the
placing of plant protection products on the market, and amending the Annex to Commission
Implementing Regulation (EU) No 540/2011
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Commission within the Standing Committee on the Food
Chain and Animal Health and were finalised on
Having regard to the Treaty on the Functioning of the European
20 November 2012 in the format of the Commission
Union,
review report for Zucchini Yellow Mosaic Virus — weak
strain.
Having regard to Regulation (EC) No 1107/2009 of the
European Parliament and of the Council of 21 October 2009
(5)
It has appeared from the various examinations made that
concerning the placing of plant protection products on the
plant protection products containing Zucchini Yellow
market and repealing Council Directives 79/117/EEC and
Mosaic Virus — weak strain may be expected to satisfy,
91/414/EEC ( 1 ), and in particular Article 13(2) and Article 78(2)
in general, the requirements laid down in Article 5(1)(a)
thereof,
and (b) and Article 5(3) of Directive 91/414/EEC, in
particular with regard to the uses which were examined
Whereas:
and detailed in the Commission review report. It is
therefore appropriate to approve Zucchini Yellow Mosaic
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
Virus — weak strain.
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply,
with respect to the procedure and the conditions for
(6) A
reasonable
period
should
be
allowed
to
elapse
before
approval, to active substances for which a decision has
approval in order to permit Member States and the
been adopted in accordance with Article 6(3) of that
interested parties to prepare themselves to meet the
Directive before 14 June 2011. For Zucchini Yellow
new requirements resulting from the approval.
Mosaic Virus — weak strain the conditions of
Article 80(1)(a) of Regulation (EC) No 1107/2009 are
(7) Without
prejudice
to
the
obligations
provided
for
in
fulfilled by Commission Decision 2006/586/EC (
Regulation (EC) No 1107/2009 as a consequence of

3 ).
approval, taking into account the specific situation
created by the transition from Directive 91/414/EEC to
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
the United Kingdom received on 16 March 2005 an
Regulation (EC) No 1107/2009, the following should,
application from Bio-Oz Biotechnologies Ltd for the
however, apply. Member States should be allowed a
inclusion of the active substance Zucchini Yellow Mosaic
period of six months after approval to review authori
Virus — weak strain in Annex I to Directive 91/414/EEC.
sations of plant protection products containing Zucchini
Decision 2006/586/EC confirmed that the dossier was
Yellow Mosaic Virus — weak strain. Member States
‘complete’ in the sense that it could be considered as
should, as appropriate, vary, replace or withdraw auth
satisfying, in principle, the data and information
orisations. By way of derogation from that deadline, a
requirements of Annexes II and III to Directive
longer period should be provided for the submission and
91/414/EEC.
assessment of the update of the complete Annex III
dossier, as set out in Directive 91/414/EEC, of each
plant protection product for each intended use in
(3) For
that
active
substance,
the
effects
on
human
and
animal health and the environment have been assessed,
accordance with the uniform principles.
in accordance with the provisions of Article 6(2) and (4)
of Directive 91/414/EEC, for the uses proposed by the
(8) The
experience
gained
from
inclusions
in
Annex
I
to
Directive 91/414/EEC of active substances assessed in
applicant. The designated rapporteur Member State
the framework of Commission Regulation (EEC) No
submitted a draft assessment report on 30 June 2006.
3600/92 of 11 December 1992 laying down the
detailed rules for the implementation of the first stage
(4) The
draft
assessment
report
was
reviewed
by
the
Member
of the programme of work referred to in Article 8(2) of
States and the European Food Safety Authority (here
Council Directive 91/414/EEC concerning the placing of
inafter ‘the Authority’). The Authority presented to the
plant protection products on the market (
Commission its conclusion on the review of the pesticide

5 ) has shown
that difficulties can arise in interpreting the duties of
risk assessment of the active substance Zucchini Yellow
holders of existing authorisations in relation to access
Mosaic Virus — weak strain ( 4 ) on 28 May 2012. The
to data. In order to avoid further difficulties it therefore
draft assessment report and the conclusion of the
appears necessary to clarify the duties of the Member
Authority were reviewed by the Member States and the
States, especially the duty to verify that the holder of
an authorisation demonstrates access to a dossier
( 1 ) OJ L 309, 24.11.2009, p. 1.
satisfying the requirements of Annex II to that Directive.
( 2 ) OJ L 230, 19.8.1991, p. 1.
However, this clarification does not impose any new
( 3 ) OJ L 236, 31.8.2006, p. 31.
( 4 ) EFSA Journal 2012; 10(6):2754. Available online: www.efsa.europa.
eu
( 5 ) OJ L 366, 15.12.1992, p. 10.

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L 350/56
EN
Official Journal of the European Union
20.12.2012
obligations on Member States or holders of authori
Mosaic Virus — weak strain as either the only active substance
sations compared to the Directives which have been
or as one of several active substances, all of which were listed in
adopted until now amending Annex I to that Directive
the Annex to Implementing Regulation (EU) No 540/2011 by
or the Regulations approving active substances.
31 May 2013 at the latest, Member States shall re-evaluate the
product in accordance with the uniform principles, as referred
(9) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No to in Article 29(6) of Regulation (EC) No 1107/2009, on the
1107/2009, the Annex to Commission Implementing
basis of a dossier satisfying the requirements of Annex III to
Regulation (EU) No 540/2011 of 25 May 2011 imple
Directive 91/414/EEC and taking into account the column on
menting Regulation (EC) No 1107/2009 of the European
specific provisions of Annex I to this Regulation. On the basis
Parliament and of the Council as regards the list of
of that evaluation, they shall determine whether the product
approved active substances
( 1 ) should be amended
satisfies the conditions set out in Article 29(1) of Regulation
accordingly.
(EC) No 1107/2009.
(10) The
measures
provided
for
in
this
Regulation
are
in
Following that determination Member States shall:
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(a) in the case of a product containing Zucchini Yellow Mosaic
HAS ADOPTED THIS REGULATION:
Virus — weak strain as the only active substance, where
necessary, amend or withdraw the authorisation by
Article 1
30 November 2014 at the latest; or
Approval of active substance
(b) in the case of a product containing Zucchini Yellow Mosaic
The active substance Zucchini Yellow Mosaic Virus — weak strain,
Virus — weak strain as one of several active substances,
as specified in Annex I, is approved subject to the conditions
where necessary, amend or withdraw the authorisation by
laid down in that Annex.
30 November 2014 or by the date fixed for such an
amendment or withdrawal in the respective act or acts
Article 2
which added the relevant substance or substances to
Annex I to Directive 91/414/EEC or approved the
Re-evaluation of plant protection products
substance or substances, whichever is the latest.
1. Member
States
shall
in
accordance
with
Regulation
(EC)
No 1107/2009, where necessary, amend or withdraw existing
Article 3
authorisations for plant protection products containing Zucchini
Yellow Mosaic Virus — weak strain as an active substance by
Amendments to Implementing Regulation (EU) No
30 November 2013.
540/2011
The Annex to Implementing Regulation (EU) No 540/2011 is
By that date they shall in particular verify that the conditions in
amended in accordance with Annex II to this Regulation.
Annex I to this Regulation are met, with the exception of those
identified in the column on specific provisions of that Annex,
and that the holder of the authorisation has, or has access to, a
Article 4
dossier satisfying the requirements of Annex II to Directive
Entry into force and date of application
91/414/EEC in accordance with the conditions of Article 13(1)
to (4) of that Directive and Article 62 of Regulation (EC)
This Regulation shall enter into force on the twentieth day
No 1107/2009.
following that of its publication in the Official Journal of the
European Union.
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
orised plant protection product containing Zucchini Yellow
It shall apply from 1 June 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 19 December 2012.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 153, 11.6.2011, p. 1.

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20.12.2012 Off
ANNEX I
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Zucchini Yellow Mosaic Not applicable
≥ 0,05 mg/l 1
June
2013 31
May
2023 For
the
implementation
of
the
uniform
principles
as
referred
to
in
Article
29(6)
of
Virus — weak strain
Regulation (EC) No 1107/2009, the conclusions of the review report on Zucchini Yellow
EN
Mosaic Virus — weak strain, and in particular Appendices I and II thereof, as finalised in

ATCC accession
the Standing Committee on the Food Chain and Animal Health on 20 November 2012
number: PV-593
shall be taken into account.
In this overall assessment Member States shall pay particular attention to the risk to non-
target plants, if the crop plants are co-infected with another virus which can be trans
mitted by aphids.
Conditions of use shall include risk mitigation measures, where appropriate.
(1 ) Further details on identity and specification of active substance are provided in the review report.
icial
Jour
nal
of
the
European
Union
L
350/57

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L 350/58
ANNEX II
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
Number
Common Name,
Identification Numbers
IUPAC Name Purity
(*) Date
of
approval Expiration
of
approval Specific
provisions
EN
‘30 Zucchini
Yellow
Mosaic
Virus — weak strain Not applicable
≥ 0,05 mg/l 1
June
2013 31
May
2023 For
the
implementation
of
the
uniform
principles
as
referred
to in Article 29(6) of Regulation (EC) No 1107/2009, the
ATCC accession number: PV-593
conclusions of the review report on Zucchini Yellow Mosaic
Virus — weak strain, and in particular Appendices I and II
thereof, as finalised in the Standing Committee on the Food
Chain and Animal Health on 20 November 2012 shall be
taken into account.
In this overall assessment Member States shall pay particular
attention to the risk to non-target plants, if the crop plants
are co-infected with another virus which can be transmitted
Off
by aphids.
icial
Conditions of use shall include risk mitigation measures,
Jour
where appropriate.’
nal
(*) Further details on identity and specification of active substance are provided in the review report.
of
the
European
Union
20.12.2012

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Document Outline

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